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Lumoxiti Injection Approved for Hairy Cell Leukemia

Cleared for Adults with Relapsed or Refractory Disease

Lumoxiti injection (moxetumomab pasudotox-tdfk, Astra Zeneca) has been approved to treat certain instances of relapsed or refractory "hairy cell" leukemia (HCL) in adults. The new drug is the latest addition to a novel class of drugs called CD22-directed cytotoxins to treat HCL, the FDA announced. The drug was approved for adults who have had at least two prior therapies for the disease.

Lumoxiti was evaluated in a clinical study of 80 people who had been treated previously for HCL. The most common side effects included injection-related reactions, swelling, nausea, fatigue, headache, fever, constipation, anemia, and diarrhea.

The drug's label includes a boxed warning of increased risk for capillary leak syndrome, and also notes an increased risk of hemolytic uremic syndrome. Breastfeeding women should not take the drug.